Exercise Intervention in Institutionalized Elderly People

Physical Disability Clinical Trial

— BENENFIT  

Official title:

Effects of Exercise on ADL Performance, Physical Fitness, and Care Dependency in Institutionalized Elderly People

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01646632
• Other study ID #: ABR NL 24558.042.09
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 11, 2012
• Last updated: July 18, 2012
• Start date: October 2009
• Est. completion date: February 2013

Study information

• Verified date: July 2012
• Source: Hanze University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

Questions: Does an evidence-based exercise program increase activities of daily living and physical fitness in institutionalized older adults? Does this program decrease the care dependency of institutionalized older adults? Design: A randomized control trial using group-based exercise was performed in 14 assisted-living facilities for the elderly (>70 years old).

Outcome measures: Outcome measures were performance on ADL, physical fitness, and care dependency measures. The exercise program comprised group-based progressive resistance training, balance training, and functional training. The control intervention comprised social group meetings.

Description:

To improve physical fitness, a combined exercise program including progressive resistance training, balance training, and functional training will be used in a sample of institutionalized elderly people. The exercise program has a frequency of 2 times a week and a duration of 16 weeks. The intensity is moderate, measured on a 0-10 scale. The level of intensity is specified as follows: on a 10- point scale, where no movement is 0 and maximal effort of a muscle group is 10, moderate-intensity effort is a 5 or 6, and high- intensity effort is a 7 or 8. There is currently insufficient evidence that a combined exercise program, developed to improve physical fitness, can improve ADL performance and care dependency also.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 164
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Age 70 and older

• Being able to walk at least 10 meters

• Not cognitive impaired

Exclusion Criteria:

• Dementia

• Severe hart failure

• Progressive neurological diseases

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fragility
• Physical Disability

Intervention

Behavioral:
• Physical exercise intervention
the experimental intervention included group- based progressive resistance training, balance training, and functional training, two times a week, one hour sessions, lasting 16 weeks.
• Lifestyle counseling
the control intervention included recreational sessions, including talks, video's, music, board games etc. No physical activity was involved in the control intervention.

Locations

Country	Name	City	State
Netherlands	Hanze University Applied Sciences	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
Hanze University	University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Weening-Dijksterhuis E, de Greef MH, Scherder EJ, Slaets JP, van der Schans CP. Frail institutionalized older persons: A comprehensive review on physical exercise, physical fitness, activities of daily living, and quality-of-life. Am J Phys Med Rehabil. 2011 Feb;90(2):156-68. doi: 10.1097/PHM.0b013e3181f703ef. Review. — View Citation

Weening-Dijksterhuis E, Kamsma YP, van Heuvelen MJ. Psychometric properties of the PAT: an assessment tool for ADL performance of older people living in residential homes. Gerontology. 2011;57(5):405-13. doi: 10.1159/000318151. Epub 2010 Aug 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADL performance in institutionalized elderly people	the intervention was either an group -based exercise program (the experimental intervention), or a recreational program (the control intervention), lasting 16 weeks, two times a week, including one hour sessions	16 weeks	No
Secondary	Physical fitness in institutionalized older people	the intervention was either an group -based exercise program (the experimental intervention), or a recreational program (the control intervention), lasting 16 weeks, two times a week, including one hour sessions	16 weeks	No
Secondary	Care dependency in institutionalized older people	the intervention was either an group -based exercise program (the experimental intervention), or a recreational program (the control intervention), lasting 16 weeks, two times a week, including one hour sessions	16 weeks	No